Fernando Atienza

What the practice is

Fernando Atienza is an independent consultant and industrial engineer specializing in electronics. He has worked on his own account in medical-device consulting since 2018, with services centered on compliance with the European Medical Device Regulation, MDR 2017/745.

Specialties

His technical and regulatory work includes:

• Medical-device regulatory compliance under MDR 2017/745
• ISO 13485 quality-management systems
• Risk management
• Technical and clinical evaluation
• Process improvement using the plan-do-check-act cycle

Background

Atienza reports more than 12 years as a consulting engineer connected with hospitals. His experience spans hospital telecommunications, special-installation design, turnkey systems and product responsibility in hospital and social-care settings, with an increasing focus on requirements and compliance. He later specialized in medical-device regulatory affairs and mechanical installations.

He created productosanitario.es in 2017 as an educational resource and terminology reference for the sector and began independent practice the following year.

Additional resources

The business provides online courses about medical devices and publishes regulatory updates for industry professionals.

A consulting engagement can identify product classification, intended purpose, applicable standards, technical documentation, clinical evidence, quality-system responsibilities, deliverables and regulatory deadlines.